Sensara
by Sensara B.V.
Ref SC-0001
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number72089285100SC-0001Z6 | Date8 Jan 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SensaraConnect
- Model / Reference
- SC-0001
- Primary DI / UDI-DI
- 87208928510017, 87208928510024
- Basic UDI-DI
- 72089285100SC-0001Z6, 872089285100SC-0001DB
- Direct Marketing DI
- 8720892851001787208928510024
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000050450
Other devices from Sensara B.V.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No